1. Field of the Invention
The present invention relates to medical devices and more particularly to access devices and particularly their seal arrangements and closure mechanisms applicable to such medical devices, and is based upon and incorporates herein Provisional Application Ser. No. 60/461,149 filed 8 Apr. 2003 by reference.
2. Prior Art
Laparoscopic surgery is now standard procedure in hospitals today. Abdominal operations are being performed with narrow elongated instruments inserted through small incisions into interior portions of the body. Such laparoscopic procedures are now considered the treatment of choice for operations such as the removal of the gall bladder, spleen, adrenal glands, uterus and ovaries. Such laparoscopic procedures are accomplished via access through a device typically known as a trocar which facilitates the introduction of laparoscopic instruments into the abdomen of the body. The introductions of these instruments typically are done in regions which include a fluid under pressure. In the abdomen, this fluid may be a gas such as insufflation gas. It is desirable to provide for the introduction of a surgical instrument into the body cavity without permitting the reduction or loss of the operative pneumoperitoneum.
During typical laparoscopic procedures, the surgeon makes three to four small incisions, usually no larger than about twelve millimeters. These facial incisions are made with the trocar devices. The trocar makes the incision and then provides a tubular access for other instruments to be inserted into the abdominal space. The trocar also provides a means to insufflate the abdominal cavity with a low pressure gas, typically carbon dioxide, so that the surgeon has an open interior space in which to work. The trocar must provide a means to maintain the internal gas pressure with some sort of a seal between the trocar and the medical instrument he is utilizing, and still allow those surgical devices to be inserted and withdrawn. Such surgical instruments introduced through the trocar tube and into the abdomen may include scissors, grasping instruments, occluding instruments, cauterizing units, cameras, light sources and other surgical instruments.
Currently, insufflation is performed by providing a regulated pressurized gas to the peritoneal cavity via the trocar cannula. This gas, typically carbon dioxide, is supplied to a connection on the side of the trocar tube by a flexible hose thereattached. The medical instrument going through the trocar or innermost tube thereof, should be sealed relative to the trocar so that insufflation gas will not escape from the patient.
Sealing mechanisms are utilized within the trocar to prevent the escape of fluid. Such mechanisms said typically comprised an aperture or septum valve which has functioned to form a seal around the outer surface of the instrument positioned and moved within the trocar or access device. When the instrument is inserted, or is removed, the hole in the seal contracts to restrict outward gas flow. Such seals usually accept a range of instrument diameters and usually do not totally restrict outward gas flow when these instruments are retracted. Other types of valves and seals include flapper valves or trap type doors which are spring loaded. When a instrument penetrates the trocar tube access device the instrument pushes the door open. However when the instrument is retracted, such a trap door or valve may interfere with the removal of the instrument or any tissue being transported thereby.
Certain problems arise with the types of seals utilized in these trocar devices. Certain seals only work for a limited range of instrument diameters. Certain other seals inhibit the motion of the instrument as it is being inserted or as it is being withdrawn from the trocar. Typically the seals do not last through any procedures because they are subject to wear and tearing. Those prior art seals also may often interfere with the removal of the instrument and/or any tissue being withdraw from the patient utilizing that particular instrument.
It is an object of the present invention to overcome the disadvantages of the prior art.
It is a further object of the present invention to provide a seal which will work with a wide range of instrument sizes, shapes and diameters.
It is a further object of the present invention to provide a universal trocar seal for use without the seal interfering with or touching any instrument utilized therewith.
It is still yet a further object of the present invention to provide a seal which will eliminate any motion restriction for those instruments inserted therethrough, and permit improved tactile feedback to the surgeon.
It is yet a further object of the present invention to provide a seal which may be automatic in its function, as well as being controllable and adjustable, by or according to the needs of the attending surgeon.
It is a further object of the present invention to provide a path for exiting liquid and gas and a collection arrangement therefore, with a prevention of any splash therewith.
It is still yet a further object of the present invention to provide a seal which will not interfere with the removal of tissue from the interior of a body cavity as it moves through the trocar.
It is still yet a further object of the present invention to allow instruments with an irregular outside surface configuration to still maintain a seal with the trocar.
It is yet another object of the present invention to allow an instrument and a trailing suture to be utilized as in a surgical procedure such as a Nissen fundal placation.
It is yet a further object of the present invention to permit the use of two instruments with a combined OD less than the ID of the cannula wherein one instrument could be used for grasping and stabilizing tissue the other instrument used for cutting that stabilized tissue or cannulation (cholangiogram) of a ductal tissue without the loss of gas or the use of a further trocar.